How Effective is Testosterone Replacement Therapy in Premenopausal Women with Severe Androgen Deficiency?

Henry Burger

Disclosures

Nat Clin Pract Endocrinol Metab. 2006;2(8):432-433. 

In This Article

Synopsis

Background: Hypopituitarism in women can cause adrenal and ovarian dysfunction, resulting in severe androgen deficiency. Although testosterone replacement therapy has been shown to be beneficial in androgen-deficient men, its effects in women are unclear.
Objective: To assess the efficacy of low-dose testosterone replacement therapy in androgen-deficient premenopausal women with hypopituitarism.
Design and Intervention: This 12-month, randomized, double-blind, placebo-controlled trial enrolled women aged 19-50 years with hypopituitarism leading to hypogonadism and/or adrenal insufficiency. Eligible participants had a serum free testosterone level <10.75 pmol/l, were estrogen replete, and were either growth-hormone-naive or else had been receiving a stable dose of growth hormone for >2 years. Exclusion criteria included androgen therapy or treatment with agents known to affect BMD within 1 year before enrollment. Participants received a total of 300µg transdermal testosterone, given as two 150µg patches, or two placebo patches. Free testosterone levels were monitored and the dose reduced to 150µg if necessary; however, increases in dose were not made. Study visits were carried out at baseline and at 3-month intervals thereafter, and included measurement of testosterone levels, BMD, and body composition. The Beck Depression Inventory was used to assess mood and the Derogatis Interview for Sexual Functioning was used to determine sexual function; in addition, general health, quality of life, and cognition were also measured.
Outcome Measures: The primary outcome measures were BMD, body composition, and behavioral function.
Results: A total of 24 women received testosterone and 27 received placebo. Baseline characteristics were similar, with pituitary adenomas being the most common cause of hypopituitarism. Overall, 59% of participants were depressed and 68% had reduced sexual functioning. Mean free testosterone levels were below the normal range for women of reproductive age at baseline, but increased with testosterone treatment. Testosterone significantly increased BMD at the hip (P = 0.023) and radius (P = 0.007), but not the posteroanterior spine. Compared with placebo, testosterone increased fat-free mass (P = 0.040) and muscle area at the mid-femur (P = 0.038); however, total, intra-abdominal, and subcutaneous fat cross-sectional area and body weight were not affected. Beneficial effects of testosterone on mood (P = 0.029) and sexual functioning (P = 0.044) were observed. There was also a marked improvement in the general health and quality of life of patients receiving testosterone, although changes in cognition were limited. Women receiving testosterone had a 6% mean increase in total cholesterol levels when compared with those receiving placebo. Acne was reported by 8 women receiving testosterone, compared with only one woman in the placebo group (P = 0.004). The most common adverse effect in both groups was skin irritation at the patch application site.
Conclusion: Low-dose testosterone was well tolerated and associated with improvements in BMD, body composition, mood, sexual function, and quality of life.

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